Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486170
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2020-07-08
Brief Title:
Assessment of Postpartum Education to Improve Compliance
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Assessment of Patient Education as a Method of Optimizing Postpartum Care in Women With Hypertension
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single centered randomized control study for postpartum patients diagnosed with hypertension Participants that meet inclusion criteria will be approached while they are inpatient After enrollment all study subjects will receive an automated blood pressure cuff and instructions on how to use it Study participants in the intervention group will be provided with educational material The investigators hypothesize education in postpartum women with hypertension can improve patient compliance with attendance at postpartum care appointments
Detailed Description:
The study group postpartum women with a diagnosis of either chronic hypertension gestational hypertension preeclampsia without severe features preeclampsia with severe features chronic hypertension with superimposed preeclampsia with and without severe features
Recruitment postpartum patients that meet the inclusion criteria will be approached postpartum while they are still hospitalized Once the study subjects are enrolled they will receive the same automatic blood pressure cuff and basic teaching on how to use it All study subjects will be asked to check their blood pressure once a day The study subjects will be advised that if systolic blood pressure is 160 or the diastolic blood pressure 110 the study subjects are asked to remain seated and repeat the BP measurement in 15 minutes if still elevated the study subject will be advised to call labor and delivery or proceed to labor and delivery triage for further evaluation All study subjects will be asked to follow up for a blood pressure check 3-10 days after discharge home All study subjects will be weighed prior to discharge
The study subject is then randomized to the control or intervention group Both groups will receive a survey After the intervention group undergoes the educational component this will be the last time the study subjects meet with the investigator
The data will be collected on an excel spreadsheet Patient identifiers will be removed once the study is completed However de-identified data may be used for future studies The database will be password protected on an excel spreadsheet and secured behind the Medstar Washington Hospital Center firewall computers Access to these databases is restricted to the PI and the co-investigators The data will be statistically analyzed in order to answer the primary and secondary outcomes
Power analysis At Washington hospital center the current attendance within 10 day postpartum follow up appointments is 40 and at the 6 week appointment it is 70 Based on this data the investigator wants to evaluate if this postpartum education intervention can cause a 100 difference in attendance within 10 days postpartum 40 attendance which is the current attendance rate control versus 80 goal for the intervention group enrollment of 46 patients is required
Recruitment postpartum patients that meet the inclusion criteria will be approached postpartum while they are still hospitalized Once the study subjects are enrolled they will receive the same automatic blood pressure cuff and basic teaching on how to use it All study subjects will be asked to check their blood pressure once a day The study subjects will be advised that if systolic blood pressure is 160 or the diastolic blood pressure 110 the study subjects are asked to remain seated and repeat the BP measurement in 15 minutes if still elevated the study subject will be advised to call labor and delivery or proceed to labor and delivery triage for further evaluation All study subjects will be asked to follow up for a blood pressure check 3-10 days after discharge home All study subjects will be weighed prior to discharge
The study subject is then randomized to the control or intervention group Both groups will receive a survey After the intervention group undergoes the educational component this will be the last time the study subjects meet with the investigator
The data will be collected on an excel spreadsheet Patient identifiers will be removed once the study is completed However de-identified data may be used for future studies The database will be password protected on an excel spreadsheet and secured behind the Medstar Washington Hospital Center firewall computers Access to these databases is restricted to the PI and the co-investigators The data will be statistically analyzed in order to answer the primary and secondary outcomes
Power analysis At Washington hospital center the current attendance within 10 day postpartum follow up appointments is 40 and at the 6 week appointment it is 70 Based on this data the investigator wants to evaluate if this postpartum education intervention can cause a 100 difference in attendance within 10 days postpartum 40 attendance which is the current attendance rate control versus 80 goal for the intervention group enrollment of 46 patients is required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None